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

Model Number	G30958
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).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
As reported, during a recanalization procedure of the superficial femoral artery via contralateral approach, involving an (b)(6) year-old male patient with critical limb ischemia, an advance 18 lp low profile balloon catheter "broke in half" upon removal of the device.A cook flexor 6 french, 45 centimeter sheath was used during the procedure as well as an unknown inflation device and another manufacturer's 0.018 inch wire guide.The complaint device was inflated at least four times with a 1:3 ratio of contrast to saline to 8-10 atmospheres each time for 60-120 seconds prior to the event.The device was not removed from the body but was repositioned within the target vessel.The iliac vessels were reportedly tortuous and severely calcified.The target lesion, reported as "all along the superficial femoral artery", was "1/6 " occluded.The device balloon reportedly ruptured circumferentially and "the wire location disconnected from the balloon".Blood was noted in the inflation device and the balloon was allowed to return to ambient pressure with mild negative pressure maintained.During removal of the balloon (by itself), the balloon separated into two parts within the sheath, over the wire guide.A counterclockwise rotation of the balloon was not conducted upon removal of the device.The "end part" of the balloon was removed using another catheter.A section of the device did not remain inside the patient¿s body.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
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.Reviews of the complaint history, device history record, drawing, instructions for use (ifu), and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that only part of the complaint device was returned by the customer.The balloon material was found to have been circumferentially torn completely around the balloon.The distal portion of this material was not returned as it had separated.The distal tip and shaft material between the balloon bonded areas was also separated.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, reviews of the drawings and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which states the intended use of the device is outlined as being designed for percutaneous transluminal angioplasty (pta) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.The ifu includes warnings against exceeding the rated burst pressure and to use an inflation device equipped with a pressure gauge to monitor the inflation pressures.The product labeling, as noted on the work order sample, includes indications that the device is compatible with a 4 french introducer sheath.The ifu also calls out for the catheter and sheath to be removed as a unit after a rupture occurs or pressure is lost.When withdrawing the catheter, a gentle counter-clockwise rotation of the catheter will assist balloon rewrap, minimizing resistance through the sheath.Reportedly, neither of these steps were taken.Based on the information provided and the examination of the returned product, investigation has concluded that the balloon rupture could not be traced to the device but to the patient¿s condition.Reportedly, the patient had pre-existing cli and severe calcification.The separation that followed was most likely the result of the balloon not being rotated circumferentially or removed through the sheath instead of the catheter and sheath together with the balloon material in a damaged state.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Measures are being taken to address this failure mode.Per the quality engineering risk assessment no further action is required.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 8964456
• Report Number: 1820334-2019-02219
• Device Sequence Number: 2087888
• Product Code: LIT
• UDI-Device Identifier: 10827002309583
• UDI-Public: (01)10827002309583(17)210921(10)9181330
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 11/14/2019

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: 09/21/2021
• Device Model Number: G30958
• Device Catalogue Number: PTA4-18-150-5-20
• Device Lot Number: 9181330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 11/14/2019
• 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: BOSTON SCIENTIFIC V18 WIRE, LOMERON CONTRAST; BOSTON SCIENTIFIC V18 WIRE, LOMERON CONTRAST
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Weight: 70