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

Model Number	G34331
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: (b)(6).E3: occupation: lab manager.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.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
As reported, during an intervention of the left superficial femoral artery (lsfa) post atherectomy, an advance 18 lp low profile balloon catheter's balloon ruptured.The patient's anatomy was calcified, and the lesion was 90% occluded.Another manufacturer's 5fr sheath, atherectomy device, unspecified inflation device and 5fr sheath, and cook wire guide were used during the procedure.The balloon was inflated three times, approximately six to eight seconds each time, and ruptured upon the third inflation at twelve atmospheres.Just the balloon was removed, and the procedure was continued with a new balloon and another manufacturer's balloon.Blood was not noted in the inflation device and the balloon was not inflated within a stent prior to the rupture.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures or experience any adverse effects due to the occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an intervention of the left superficial femoral artery (lsfa) post atherectomy, an advance 18 lp low profile balloon catheter's balloon ruptured.The patient's anatomy was calcified, and the lesion was 90% occluded.Another manufacturer's 5fr sheath, atherectomy device, unspecified inflation device and 5fr sheath, and cook wire guide were used during the procedure.The balloon was inflated three times, approximately six to eight seconds each time, and ruptured upon the third inflation at twelve atmospheres.Just the balloon was removed, and the procedure was continued with a new balloon and another manufacturer's balloon.Blood was not noted in the inflation device and the balloon was not inflated within a stent prior to the rupture.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures or experience any adverse effects due to the occurrence.Investigation evaluation: reviews of the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A functional test and visual inspection were conducted as well.The complaint device was returned to cook for investigation.Physical examination and testing of the returned device revealed that the balloon catheter did have a small leak that appeared to become occluded with biomatter.There was no other visible damage noticed otherwise.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found no additional complaints for this lot number.Cook also reviewed the product labeling, including the instructions for use (ifu).The user followed all provided instructions.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, returned device, and complaint file 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.Based on the information provided and the results of the investigation, cook concluded that the patient¿s anatomy contributed this incident.Since the device had a pinhole leak, it is probable that the calcified and 90% occluded vessel damaged the balloon.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 20163020
• Report Number: 1820334-2024-01193
• Device Sequence Number: 7311916
• Product Code: LIT
• UDI-Device Identifier: 10827002343310
• UDI-Public: (01)10827002343310(17)260310(10)15269321
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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: 03/10/2026
• Device Model Number: G34331
• Device Catalogue Number: PTA4-18-150-5-8
• Device Lot Number: 15269321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2023
• 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: 1.5 CSI.; 5FR ANSEL.; 5FR TERUMO SHEATH.; HYDRO ST.
• Patient Sex: Male