MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number	PTA5-35-80-7-4.0
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, during a fistulogram procedure an advance 35 lp low profile balloon catheter ruptured and a portion of the device separated.According to the initial reporter, the tortuous lesion was in a fistula of the patient's upper arm.It was further reported that there was no calcification in the vessel.The complaint device was being inflated by the physician using an unspecified inflation device with an isovue mixture of five (5) cc contrast and ten (10) cc of heparinized saline.After a gradual increase of pressure was achieved to the burst rate of 12 atm with the advance 35 lp low profile balloon catheter, it circumferentially ruptured after being inflated for two (2) minutes.A portion of the balloon catheter separated during the rupture, requiring a surgical cut down to remove the separated portion of the balloon.According to the customer representative, everything was removed from the patient, and was returned to the manufacturer in its entirety for investigation.The patient is doing well.
Event or Problem Description
Please see h10 for additional information concerning this event.
Additional Manufacturer Narrative
Additional information b5: it was reported that a "balloon angioplasty was being performed on left arm av fistula with tight stenosis.A 0.035 glidewire was advanced past the lesion.Balloon was advanced over the wire by physician.Balloon was slowly inflated over 2 minutes to burst pressure.Balloon ruptured circumferentially and fractured part of balloon had to be retrieved via cut-down procedure." investigation ¿ evaluation.A review of the complaint history, verification, device history record, documentation, instructions for use (ifu), quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the balloon had ruptured radially and longitudinally.The device catheter was separated between the two balloon bonds, which is consistent with the reported complaint.It was also noted that the two marker bands were not returned with the device.The customer iterated that no portion of the device was left in the patient and location of the marker bands was unknown.No other portion of the balloon catheter appears to be missing.The tip of the catheter was distorted and conformed to a.035 wire guide.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, the design history file was reviewed for verification and validation considerations and no gaps were found.Moreover, an ifu is included with the device which states "the rated burst pressure for this device is 12atm." it goes on to say "do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures¿.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be traced to the device.Measures are being conducted to address this failure mode.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: this report is being submitted retrospectively per fda request.The information in this report was previously submitted on 20nov2018 on a report with an incorrect follow up # 2.Therefore, this report is being submitted as a correction follow up # 1.Additional information b5: it was reported that a "balloon angioplasty was being performed on left arm av fistula with tight stenosis.A 0.035 glidewire was advanced past the lesion.Balloon was advanced over the wire by physician.Balloon was slowly inflated over 2 minutes to burst pressure.Balloon ruptured circumferentially and fractured part of balloon had to be retrieved via cut-down procedure." investigation ¿ evaluation: a review of the complaint history, verification, device history record, documentation, instructions for use (ifu), quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the balloon had ruptured radially and longitudinally.The device catheter was separated between the two balloon bonds, which is consistent with the reported complaint.It was also noted that the two marker bands were not returned with the device.The customer iterated that no portion of the device was left in the patient and location of the marker bands was unknown.No other portion of the balloon catheter appears to be missing.The tip of the catheter was distorted and conformed to a.035 wire guide.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, the design history file was reviewed for verification and validation considerations and no gaps were found.Moreover, an ifu is included with the device which states "the rated burst pressure for this device is 12atm." it goes on to say "do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures¿.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be traced to the device.Measures are being conducted to address this failure mode.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Please see h10 for additional information concerning this event.

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 8037528
• Report Number: 1820334-2018-03172
• Device Sequence Number: 1643376
• Product Code: DQY
• UDI-Device Identifier: 10827002523521
• UDI-Public: (01)10827002523521(17)210717(10)9022362
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/17/2021
• Device Catalogue Number: PTA5-35-80-7-4.0
• Device Lot Number: 9022362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 11/19/2018; Not provided
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 09/25/2023; 11/20/2018
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.035 GLIDEWIRE; UNSPECIFIED INFLATION DEVICE; UNSPECIFIED INFLATION DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 78 KG