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

Model Number	G50324
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 7 french sheath, 0.014 cto approach hydro st microwire, 2.5 mm x 120 mm balloon.Customer name and address - phone: (b)(6).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, during a balloon angioplasty of the popliteal and posterior tibial arteries, an advance 14 lp low profile balloon catheter would not fully inflate and a restriction was observed in the middle of the balloon.The user reported that two areas of the balloon would not inflate, and a "knot" was observed in the middle of the balloon upon removal of the device.Another balloon of the same type was used to complete the procedure.There has been no report that any part of the device remained in the patient's body, that the patient required any additional procedures, or that the patient experienced any adverse effects due to this event.
Additional Manufacturer Narrative
H1: this complaint was reported based on the original event description of a restriction and ¿knot¿ on the device.Risk was assessed based on the assumption that the catheter lumen was occluded in some manner.Physical examination of the returned device found two restrictions / pinched sections on the balloon itself.The balloon was successfully inflated, with the two pinched sections still present during inflation.No other damage was found to the device.Based upon the investigation and evaluation of the device, there is no obstruction of the device lumen that could lead to difficult deflation.Per a search of risk documentation and previous complaint data, there is no evidence to suggest that this device failure would be likely to cause or contribute to a death or a serious injury if the failure were to recur.Furthermore, there is no evidence that the device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury was alleged, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.
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.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
Additional information received on 04sep2020: the device was inflated to 8 atm with a 50:50 solution using an inflation device.The balloon was being inflated in a non-tortuous vessel that was noted to be calcified.Once the issue was noted the balloon was removed by itself and replaced by another manufacturers device.

• 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: 10530817
• Report Number: 1820334-2020-01679
• Device Sequence Number: 14358638
• Product Code: LIT
• UDI-Device Identifier: 10827002503240
• UDI-Public: (01)10827002503240(17)220904(10)9989170
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K170193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2021

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: 09/04/2022
• Device Model Number: G50324
• Device Catalogue Number: PTAX4-14-170-2.5-12
• Device Lot Number: 9989170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/04/2020; 01/04/2021
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 12/01/2020; 01/12/2021
• 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: MEDTRONIC 5 FR SHEATH
• Patient Age: 66 YR