MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	G50313
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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, an advance 14 lp low profile balloon catheter ruptured during an unspecified procedure involving a calcified lesion within the superficial femoral artery.Femoral access was obtained and another manufacturer's sheath and unknown inflation device were used during the procedure.The balloon ruptured upon the first inflation.The balloon was removed by itself and another manufacturer's device was used to complete the procedure.There have been no adverse effects to the patient.
Event or Problem Description
No new patient or event information to report since the previous medwatch report was submitted.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, an advance 14 lp low profile balloon catheter ruptured during an unspecified procedure involving a calcified lesion within the superficial femoral artery.Femoral access was obtained and another manufacturer's sheath and unknown inflation device were used during the procedure.The balloon ruptured upon the first inflation.The balloon was removed by itself and another manufacturer's device was used to complete the procedure.There have been no adverse effects to the patient.Investigation evaluation: reviews of the complaint history, device history record, drawings, instructions for use (ifu), specifications, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.Cook reviewed the device history record (dhr).The dhr for the complaint lot reveals no nonconformances.3 subassembly lots were found to have relevant nonconformances.Although these non-conformances are relevant to the reported failure mode, all non-conforming product was scrapped, and there are 100% inspections to capture this non-conformance.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 non-conforming product exists in house or in field.The information provided upon review of complaint file, device history record, complaint history, device master record, and design verification testing provide objective evidence to support that the device was manufactured to specification.Cook also reviewed the product labeling.The instructions for use (ifu) provides the following 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.Rupture may occur." instructions for use: balloon preparation: "choose a balloon appropriate to lesion length and vessel diameter.Upon removal from package, inspect the catheter to ensure no damage has occurred during shipping.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." how supplied: "store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The complainant stated that the lesion had calcification, therefore cook concluded that patient anatomy is the likely cause of this incident.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.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.

• Brand Name: ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12295307
• Report Number: 1820334-2021-01946
• Device Sequence Number: 3682183
• Product Code: LIT
• UDI-Device Identifier: 10827002503134
• UDI-Public: (01)10827002503134(17)230715(10)13306892
• Combination Product (Y/N): N
• PMA/510(K) Number: K170193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

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: 07/15/2023
• Device Model Number: G50313
• Device Catalogue Number: PTAX4-14-170-2-2
• Device Lot Number: 13306892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2020
• 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: TERUMO 6FR DESTINATION; TERUMO 6FR DESTINATION
• Patient Sex: Unknown