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

Model Number	G52293
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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
As reported, during a peripheral angioplasty, an advance 35 lp low profile balloon catheter ruptured at eight atmospheres.Another balloon was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information regarding event details and patient anatomy has been requested, but is not available at this time.
Event or Problem Description
Additional information was received on 21jan2020 noting that the target lesion was in the left iliac and it was 80% occluded.No sheath was utilized with the balloon catheter.According to the initial reporter the device was only inflated one time with an unspecified inflation device.The contrast to saline ratio was 1:7.No blood was noted in the inflation device, and the balloon was not inflated inside of a stent.After the rupture, the balloon device was removed alone.
Additional Manufacturer Narrative
Additional information: see b5.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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.Initial report: as reported, during a peripheral angioplasty, an advance 35 lp low profile balloon catheter ruptured after a single inflation at eight atmospheres.The device was removed, and another balloon was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation ¿ evaluation: reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, specifications, and a visual inspection of the returned device were conducted during the investigation.One used pta5-35-135-10-4.0 was returned to cook for investigation.Physical examination of the returned device confirmed that the balloon ruptured as a longitudinal tear was found in the balloon.The longitudinal tear was approximately 2cm in length measuring from the proximal bond.Additionally, a document-based investigation evaluation was performed.A review of the device history record showed no nonconforming events which could contribute to this failure mode.A review of complaint history showed no other complaints received for this product lot.Furthermore, reviews of the current manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.The information provided upon review of complaint file, device history record, complaint history, and device master record provide objective evidence to support that the device was manufactured to specification.An ifu is provided with this device, which warns, "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, which resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.¿ the complaint device was manufactured prior to the conclusion of capa implementation actions meant to address pta4 and pta5 balloon ruptures.Based on the condition of the returned complaint device, however, it cannot be confirmed that the identified root causes in the capa contributed to this incident.Based on the information provided and the examination of the returned product, investigation has concluded that a root cause for this event could not be determined.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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
• MDR Report Key: 9595711
• Report Number: 1820334-2020-00131
• Device Sequence Number: 3175563
• Product Code: DQY
• UDI-Device Identifier: 10827002522937
• UDI-Public: (01)10827002522937(17)220318(10)9597965
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/18/2022
• Device Model Number: G52293
• Device Catalogue Number: PTA5-35-135-10-4.0
• Device Lot Number: 9597965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 01/21/2020; 04/07/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 02/19/2020; 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR