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

Model Number	G52353
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 fistulagram with angioplasty using a advance 35 lp low profile balloon catheter, the balloon burst.The lesion was located in the left subclavian and was 50-60 percent occluded.There was no noted vessel angulation, tortuosity, or calcification, but there was a stent in the area in which the stent was inflated.The balloon was inflated three times to 25atm for about 1 minute each time using visipaque 50/50 contrast before rupturing.The balloon separated from the catheter.The balloon was retrieved by removing the wire, sheath, and balloon out at the same time as a unit.The procedure had been successfully completed with the complaint device by the time the device ruptured.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event summary as reported, during a fistulagram with angioplasty using a advance 35 lp low profile balloon catheter, the balloon burst.The lesion was located in the left subclavian and was 50-60 percent occluded.There was no noted vessel angulation, tortuosity, or calcification, but there was a stent in the area in which the stent was inflated.The balloon was inflated three times to 25atm for about 1 minute each time using visipaque 50/50 contrast before rupturing.The balloon separated from the catheter.The balloon was retrieved by removing the wire, sheath, and balloon out at the same time as a unit.The procedure had been successfully completed with the complaint device by the time the device ruptured.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.Investigation ¿ evaluation a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.The complainant returned one used pta5-35-80-7-6.0 balloon catheter to cook for investigation.Physical examination of the returned device showed biomatter present in the returned balloon.Inspection found a section of the catheter and balloon were completely separated.The balloon was torn longitudinally and circumferentially.Only the proximal marker band was present.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings ¿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.¿ ¿do not use a power injector for balloon inflation or injection of contrast medium through catheter lumen marked ¿distal¿.Rupture may occur.¿ balloon introduction and inflation ¿note: if resistance is met while advancing the balloon dilatation catheter, determine the cause and proceed with caution.¿ ¿inflate balloon to desired pressure.Adhere to recommended balloon inflation pressures.(see compliance card insert.)¿ ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded the user¿s failure to follow the instructions contributed to this incident.As reported, on the third inflation the physician inflated the balloon to 25 atm of pressure.The product label and compliance card indicate that for a pta5-35-80-7-6.0, the nominal inflation pressure is 8atm and the rated burst pressure is 12atm.The product ifu instructs the user to adhere to balloon inflation pressure parameters indicated in the compliance card insert.A letter will be sent to the customer advising the customer to adhere to the indicated inflation pressure parameters.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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 new patient or event information to report.

• 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: 11372687
• Report Number: 1820334-2021-00386
• Device Sequence Number: 14391087
• Product Code: DQY
• UDI-Device Identifier: 10827002523538
• UDI-Public: (01)10827002523538(17)230916(10)13432590
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2021

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: 09/16/2023
• Device Model Number: G52353
• Device Catalogue Number: PTA5-35-80-7-6.0
• Device Lot Number: 13432590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6 FR BOSTON SCIENTIFIC SHEATH.