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

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: k130293.The event is currently under investigation.A supplemental report will be submitted upon completion.
Event or Problem Description
It is alleged that an advance 18 lp low profile balloon catheter was being used for an angiogram with a lesion in the left common femoral when the balloon ruptured.It was reported that balloon was inflated with 6 atm at the time of rupture, using a 50/50 mixture of saline and contrast.The direction of burst is unknown, and vessel calcification was noted.No adverse events have been reported regarding this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used advance 18lp low profile balloon catheter was returned for investigation.Balloon would not inflate.Device was placed in decontamination solution.The balloon was able to be inflated.Leakage was detected from a pinhole from the distal tip.The proximal balloon bond was smooth, free of cracks, peeling, voids and excess foreign matter.The distal balloon bond was smooth, free of cracks, peeling, voids and excess foreign matter.The surface of the catheter was smooth, clean and free of damage.The length of the catheter was within specifications.The length of the balloon was within specifications and there was no balloon rupture.The device history record was reviewed and noted 2 non-conformances not relevant to the device failure.One non-conformance was related to foreign matter and not relevant to the device failure.One non-conformance was related to an inadequate tip and not relevant to the device failure.Per nonconformance reports, each of the aforementioned devices were scrapped.There is no evidence to suggest the product was not manufactured to current specifications.There is no evidence to suggest all items in the lot or similar devices in the field are nonconforming or defective.There is no evidence the product was damaged upon opening.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements, and that the device meets the needs of the user.Each device is shipped with instructions for use (ifu) listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure.There is mention that the patient had calcification in the vessel that could have contributed to the device failure.There is no information from the customer regarding the handling of the device prior to use.Per the ifu, "the balloon is manufactured from an extra-thinwall, high-strength, minimally-compliant material.Particular care should be taken in handling the balloon to prevent damage." based on the information provided, a definitive root cause could not be determined.It is stated that the patient had a preexisting calcified iliac and superficial femoral arteries.Calcifications can have unexpected sharp protrusions which can damage the balloon and contribute to burst and/or tear.Therefore, it is probable that the calcification within the patient's vessel contributed to the failure of the device.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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: 6746884
• Report Number: 1820334-2017-02103
• Device Sequence Number: 13819346
• Product Code: LIT
• UDI-Device Identifier: 10827002343297
• UDI-Public: (01)10827002343297(17)200217(10)7684490
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2017

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 Model Number: N/A
• Device Catalogue Number: PTA4-18-150-5-4
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR