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

Catalog Number	PTA4-18-80-4-20
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt identifier) unknown as not provided.(b)(4).The event is currently under investigation.
Event or Problem Description
During a angioplasty of sfa procedure, the balloon ruptured circumferentially, the vessel was calcified, and the balloon was inflated to just below the rbp.The balloon passed across the lesion and inflated to just below rbp.The balloon then ruptured and a portion of the balloon separated from the catheter and was left in the patient.Retrieval was attempted but unsuccessful.The decision made to stent over the piece of the balloon the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications, quality control and visual inspection of the returned device was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: ¿do not exceed rated burst pressure and do not use a power injector for balloon inflation or injection of contrast medium as rupture may occur.¿ the ifu also states, if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.The nominal inflation for this device is 8 atm and the rbp is 12 atm.The end user reported that the pressure used was just below the rbp therefore there is no reason to suspect that the balloon was overinflated.After rupture, attempts to removal through an introducer/sheath (against the ifu) would be difficult as the balloon cannot be fully deflated, making rewrap more difficult on a balloon.A balloon that burst circumferentially has an even more difficult time with rewrap, which increases the potential for separation.It is unknown whether or not the end user attempted to remove the balloon and sheath as a unit.The visual inspection of the returned device reported the balloon displays a circumferential separation.The proximal portion of the balloon measures 0.5 cm in length and the distal section was not returned.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The device is designed to burst linearly.However, a balloon may burst or tear circumferentially due to angulation or calcification.Calcifications can have unexpected sharp protrusions which can damage the balloon and contribute to burst or tear.A pre-existing condition of the patient is pad, heavily calcified vessels.Patient anatomy likely contributed to this failure mode.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the risk assessment, no further action is required.
Event or Problem Description
During a angioplasty of sfa procedure, the balloon ruptured circumferentially, the vessel was calcified, and the balloon was inflated to just below the rbp.The balloon passed across the lesion and inflated to just below rbp.The balloon then ruptured and a portion of the balloon separated from the catheter and was left in the patient.Retrieval was attempted but unsuccessful.The decision made to stent over the piece of the balloon the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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: 5660882
• Report Number: 1820334-2016-00314
• Device Sequence Number: 26748
• Product Code: LIT
• UDI-Device Identifier: 10827002308975
• UDI-Public: (01)10827002308975(17)161201(10)F4664977
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2016

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 Catalogue Number: PTA4-18-80-4-20
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/25/2016
• Device Age: 28 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2016
• Supplement Report FDA Received Date: 10/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR