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

Model Number	G30946
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1: 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.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
As reported, during an unknown vascular surgery procedure in an operating room, an advance 18 lp low profile balloon catheter separated upon attempted removal, after the balloon was inflated.Reportedly, as the user attempted to remove the balloon catheter, the catheter broke, leaving the balloon in an unknown introducer.Because the fragment was inside the introducer, the introducer was removed from the patient in order to remove the separated catheter fragment.There were no consequences to the patient.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 this occurrence.Additional information has been requested.
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 an unknown vascular surgery procedure in an operating room, an advance 18 lp low profile balloon catheter separated upon attempted removal, after the balloon was inflated.Reportedly, as the user attempted to remove the balloon catheter, the catheter broke, leaving the balloon in an unknown introducer.Because the fragment was inside the introducer, the introducer was removed from the patient in order to remove the separated catheter fragment.There were no consequences to the patient.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 this 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.The complaint device was not returned 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 lot.A review of complaint history found no additional complaints for this lot number.The product ifu states ¿apply negative pressure to lumen labeled ¿balloon¿ prior to introduction.Advance the balloon dilation catheter counterclockwise over a per-positioned.018 (0.46 mm) wire guide.¿ and ¿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, cook has concluded component failure 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.
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
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation evaluation: a visual inspection was conducted as the complaint device was returned to cook for investigation.Physical examination of the returned device showed the catheter and balloon separated into two sections.The proximal section was approximately 145cm from the distal end of the strain relief to the point of separation.The distal section was approximately 28cm in length (some bunching was noted).Review of the returned device suggests that there is evidence the device was manufactured to specification.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 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: 19938716
• Report Number: 1820334-2024-01056
• Device Sequence Number: 20665710
• Product Code: LIT
• UDI-Device Identifier: 10827002309460
• UDI-Public: (01)10827002309460(17)270130(10)15872501
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K130293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2024

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 Model Number: G30946
• Device Catalogue Number: PTA4-18-150-3-20
• Device Lot Number: 15872501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 09/30/2024; 10/11/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 10/01/2024; 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2024
• 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
• Patient Sex: Unknown