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

Model Number	G50319
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
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
As reported, 4.5fr sheath was inserted into the thrombotic occlusive lesion existing from the right popliteal artery to the posterior tibial artery.A right femoral artery approach was used.There was no angulation or vessel calcification noted.After passing through a 0.014inch wire guide, the physician dilated the lesion with the reported advance 14 lp low profile balloon catheter (2mm × 20mm).For sizing-up of the balloon catheter, the physician tried to pull the reported balloon out of the sheath, but the balloon catheter was unable to be pulled out of the sheath.Therefore, the sheath and the reported balloon catheter were removed together.After that, a new 4.5 fr sheath was inserted into the patient, and the physician used 2 advance14lp which were bigger sizes than the reported balloon catheter and dilated the lesion.The 2 advance14lp were removed from the patient's body without any problems.The procedure was completed without any problems.No adverse effects were reported due to this occurrence.
Additional Manufacturer Narrative
A review of the complaint file, risk files, and complaint history records shows that there is no precedent set for reporting such a complaint and the risk file shows the associate risk as: negligible harm.Event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death or serious injury and there is no precedence of this malfunction leading to an adverse event.H1: our system requires this field to be populated and still reflects "malfunction" there was no reportable device malfunction.
Event or Problem Description
No new patient or event information to report.

• 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
• MDR Report Key: 11273140
• Report Number: 1820334-2021-00243
• Device Sequence Number: 11636377
• Product Code: LIT
• UDI-Device Identifier: 10827002503196
• UDI-Public: (01)10827002503196(17)230713(10)13303004
• Combination Product (Y/N): N
• PMA/510(K) Number: K170193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

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: 07/13/2023
• Device Model Number: G50319
• Device Catalogue Number: PTAX4-14-170-2-20
• Device Lot Number: 13303004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 05/12/2021
• 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: 0.014INCH WIRE GUIDE (AGOSAL/ASAHI INTECC); PARENT 4.5FR/MEDIKIT
• Patient Age: 54 YR