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

Model Number	G35536
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2018
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.
Event or Problem Description
It was reported, a patient of unknown age and gender underwent a superficial femoral artery (sfa) procedure in which an advance 35 lp low profile balloon catheter was used.The complaint device was inflated to 11 or 12 atmospheres which was just above nominal pressure and the balloon burst.A ratio of contrast to saline equal to 50/50 was used for inflation.No information was provided regarding type of inflation device.The patient's anatomy was calcified but not angulated.The complaint device was removed intact with no harm to the patient.Another balloon device (manufacturer not specified) was used and the procedure was completed.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Information received (b)(6) 2019 confirms that the device associated with this event did not rupture, but rather experienced difficult advancement through a sheath.This event is no longer reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury , or product malfunction.There is no precedence of this malfunction leading to an adverse event.No additional follow-up reports will be submitted under report reference number 1820334-2019-00238.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
Information was received (b)(6) 2019 clarifying the event.It was initially reported that two separate pta devices were used in two separate procedures.However, the cook area representative has since corrected these events.In the first case (reported in 1820334-2019-00239), the pta rupture is accurate.However, the second complaint has been updated to reflect a difficult advancement/insertion of the second pta device into a 5fr cook sheath (this report).The 5fr sheath was not returned, only the second pta device that would not advance.It should be noted, the pta device is compatible with a 6fr sheath.This event is no longer reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury , or product malfunction.There is no precedence of this malfunction leading to an adverse event.No additional follow-up reports will be submitted under report reference number 1820334-2019-00238.

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8293626
• Report Number: 1820334-2019-00238
• Device Sequence Number: 1733890
• Product Code: LIT
• UDI-Device Identifier: 10827002355368
• UDI-Public: (01)10827002355368(17)211101(10)9278909
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2019

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: 11/01/2021
• Device Model Number: G35536
• Device Catalogue Number: PTA5-35-135-6-20.0
• Device Lot Number: 9278909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK RAABE SHEATH 6FR 55CM