MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G35532

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2022

Event Type  malfunction  

Manufacturer Narrative

Occupation = "head tech." this report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during an angioplasty of the superficial femoral artery, an advance 35 lp low profile balloon catheter ruptured upon inflation of the balloon.The balloon was inflated within a heavily calcified area, and sharp calcification was reported.Per the reporter, the user believes that the calcium caused the balloon to rupture.The complaint device was removed and another unknown 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.

Manufacturer Narrative

Additional information: 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.

Event Description

Additional information was received 17jun2022.A 6 french ansel sheath and an unspecified inflation device were used during the procedure.The balloon reportedly ruptured below nominal pressure, and blood was noted in the inflation device after the balloon ruptured.The balloon was not inflated within a stent.The device was removed through the sheath.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an angioplasty of the superficial femoral artery, an advance 35 lp low profile balloon catheter ruptured upon inflation of the balloon.The balloon was inflated within a heavily calcified area, and sharp calcification was reported.A 6 french ansel sheath and an unspecified inflation device were used during the procedure.The balloon reportedly ruptured below nominal pressure, and blood was noted in the inflation device after the balloon ruptured.The balloon was not inflated within a stent.Per the reporter, the user believes that the calcium caused the balloon to rupture.The complaint device was removed through the sheath, and another unknown 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, drawing, instructions for use (ifu), specifications, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.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 ¿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 vessels were heavily calcified, with sharp calcium reported.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 Description

No additional information has been received since the last report was submitted.

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Type of Device: 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: 14454491
• MDR Text Key: 292507307
• Report Number: 1820334-2022-00944
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002355320
• UDI-Public: (01)10827002355320(17)250103(10)14445829
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2022

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
• Device Operator: Health Professional
• Device Model Number: G35532
• Device Catalogue Number: PTA5-35-135-5-20.0
• Device Lot Number: 14445829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 06/17/2022; 08/19/2022
• Supplement Dates FDA Received: 06/28/2022; 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1