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

Catalog Number	PTAX4-14-170-2-20
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
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.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 a percutaneous transluminal angioplasty (pta), an advance 14 lp low profile balloon catheter ruptured.Antegrade approach from the right femoral artery for a lesion below the knee was obtained with another manufacturer's wire guide.The balloon catheter was advanced through the calcified vessel and inflated within nominal pressure and subsequently ruptured.The balloon catheter was removed, and the procedure was completed with another same type device.A section of the device did not remain inside the patient.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Summary of event: as reported, during a percutaneous transluminal angioplasty (pta), an advance 14 lp low profile balloon catheter ruptured.Antegrade approach from the right femoral artery for a lesion below the knee was obtained with another manufacturer's wire guide.The balloon catheter was advanced through the calcified vessel and inflated within nominal pressure and subsequently ruptured.The balloon catheter was removed, and the procedure was completed with another same type device.A section of the device did not remain inside the patient.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), drawings, specifications, and quality control procedures were conducted during the investigation.The complainant did not return the complaint device to cook for investigation.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the final lot.A review of complaint history found no additional complaints for this lot number.The catheter component lot associated with the complaint lot records a relevant non-conformance for ¿failed leak test¿ for a quantity 2.This component lot was used in four other final lots.A database search for complaints on these lots found no additional complaints reported.Although there was a relevant non-conformance to the reported failure mode found in the catheter component lots, all non-conforming product was scrapped prior to release and there are 100% inspections in place to capture this non-conformance.No other lot related complaints have been received from the field.Cook also reviewed product labeling.The product ifu, [t_ptax_rev7] ¿advance 14lp low profile pta balloon dilatation catheter,¿ provides the following information to the user related to the reported failure mode: balloon introduction and inflation: ¿2.Apply negative pressure to lumen labeled ¿balloon¿ prior to introduction.Advance the balloon dilation catheter counter-clockwise over a per-positioned.018 (0.46 mm) wire guide.¿ ¿6.If balloon pressure is lost and/ or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.¿ 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, 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, and with no device returned for examination, there are no manufacturing or design deficiencies that can be confirmed at this time.The exact conditions experienced during the event cannot be duplicated, therefore, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.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.

• 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: 18312007
• Report Number: 1820334-2023-01682
• Device Sequence Number: 6604664
• Product Code: LIT
• UDI-Device Identifier: 10827002503196
• UDI-Public: (01)10827002503196(17)260406(10)15373970
• Combination Product (Y/N): N
• PMA/510(K) Number: K170193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2024

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: 04/06/2026
• Device Catalogue Number: PTAX4-14-170-2-20
• Device Lot Number: 15373970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2023
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2023
• 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: ASAHI INTECC/GLADIUS PP14R200PR 0.014INCH 235CM; MEDIKIT/PA0036/4.5FR
• Patient Sex: Male