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

Catalog Number	PTA4-18-150-6-12
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products- abbott supera stent, cook.014 hydro st wire guide, cook 6fr x 45cm ansel sheath, unspecified ensnare, cook sphere inflation device.Pma/510(k) number- k130293.(b)(4).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 that during a superficial femoral artery (sfa) intervention, an advance 18 lp low profile balloon catheter ruptured and separated.The balloon device was inflated in the distal sfa using isoview 50/50 mixture.The device was inflated to nominal pressure inside another manufacturer's stent when it circumferentially ruptured.Reported pre-existing conditions include peripheral artery disease, diabetes, and hypertension.There has been no report of angulation or calcification regarding the patient anatomy.Upon removal of the balloon device, it was observed that a portion of the balloon material separated and was snared using another manufacturer's device.The procedure was completed successfully.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not 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
Investigation ¿ evaluation.A review of the dimensional verification, complaint history, device history record, drawing, instructions for use (ifu), quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the balloon had separated between the distal balloon and the catheter material.The balloon separation revealed both longitudinal and circumferential tears.The catheter section beneath the balloon material appeared elongated, indicative of being stretched while removing the device.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, a review of the device history file and quality control procedures was conducted, and no gaps were discovered.Based on the information provided and the examination of the returned product, investigation has concluded that the cause cannot be traced to the device, but instead is related to the procedure.The balloon was reportedly inflated inside a previously placed stent, and it is likely that an exposed section of the stent could have compromised the integrity of the balloon.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Measures are being conducted to address this failure mode.Per the quality engineering risk assessment no further action is required.

• 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
• MDR Report Key: 8103217
• Report Number: 1820334-2018-03482
• Device Sequence Number: 1204009
• Product Code: LIT
• UDI-Device Identifier: 10827002309613
• UDI-Public: (01)10827002309613(17)210816(10)9100394
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2021
• Device Catalogue Number: PTA4-18-150-6-12
• Device Lot Number: 9100394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 02/13/2019
• 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: .
• Outcome Attributed to Adverse Event: Required Intervention