MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	G30903
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during percutaneous transluminal angioplasty of the lower limb, an advance 18 lp low profile balloon catheter ruptured and separated.Per the user, after the balloon ruptured, half of the balloon and balloon catheter separated upon removal of the device.Reportedly, the user felt "something like a structural weakness".An open endarterectomy using sedoanalgesia was performed to retrieve the balloon and balloon catheter from the superficial femoral artery.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Customer name and address: (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
No additional information has been received since the last report was submitted.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during percutaneous transluminal angioplasty of the lower limb, an advance 18 lp low profile balloon catheter ruptured and separated.Per the user, after the balloon ruptured, half of the balloon and balloon catheter separated upon removal of the device.Reportedly, the user felt "something like a structural weakness".An open endarterectomy using sedoanalgesia was performed to retrieve the balloon and balloon catheter from the superficial femoral artery.Additional information was received 20may2022.Another manufacturer's 5 french sheath was used during the procedure.The device was inflated one time, using a mixture of visipaque 270 contrast and saline, to ten atmospheres.The balloon ruptured circumferentially after five minutes.Blood was noted in the inflation device upon withdrawal of the balloon over an unknown wire.Reportedly, negative pressure was maintained; however, a counterclockwise rotation was not conducted upon removal.The balloon was not inflated within a stent.The anatomy was tortuous, and calcification was described as "massive".The lesion in the popliteal artery was 90% occluded.Reportedly, the sheath and half of the balloon were removed together, then "stenting" was conducted.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, drawing, instructions for use (ifu), and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.Photos were provided by the user confirming that the balloon and catheter separated.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The product ifu warns against over-inflation of the device, as rupture may occur.Per the device label, the rated burst pressure for this device is twelve atmospheres, and the nominal pressure is eight atmospheres.The ifu instructs the user to deflate the balloon and remove the balloon and sheath as a unit if rupture occurs.The ifu states, ¿if resistance is met during withdrawal, apply negative pressure with a larger syringe before proceeding.If resistance continues, remove balloon and sheath as a unit.¿ the information provided upon review of the dmr, dhr, and ifu suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s anatomy contributed to this event, as the lesion was reportedly ¿massively¿ calcified and ninety percent occluded.It has been concluded that the shaft separation is likely a cascading failure due to the additional stress placed on the catheter resulting from the circumferential rupture.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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.
Event or Problem Description
Additional information was received 20may2022.Another manufacturer's 5 french sheath was used during the procedure.The device was inflated one time, using a mixture of visipaque 270 contrast and saline, to ten atmospheres.The balloon ruptured circumferentially after five minutes.Blood was noted in the inflation device upon withdrawal of the balloon over an unknown wire.Reportedly, negative pressure was maintained; however, a counter-clockwise rotation was not conducted upon removal.The balloon was not inflated within a stent.The anatomy was tortuous and calcification was described as "massive".The lesion in the popliteal artery was 90% occluded.Reportedly, the sheath and half of the balloon were removed together, then "stenting" was conducted.
Additional Manufacturer Narrative
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.

• Brand Name: ADVANCE 18 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: 14083545
• Report Number: 1820334-2022-00558
• Device Sequence Number: 13990126
• Product Code: LIT
• UDI-Device Identifier: 10827002309033
• UDI-Public: (01)10827002309033(17)241121(10)14368903
• Combination Product (Y/N): N
• PMA/510(K) Number: K130293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2022

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: 11/21/2024
• Device Model Number: G30903
• Device Catalogue Number: PTA4-18-80-5-20
• Device Lot Number: 14368903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 05/20/2022; 06/06/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 05/24/2022; 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2021
• 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: 5 FR CORDIS BRITE TIP SHEATH; 5 FRENCH CORDIS SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 90 KG