MAUDE Adverse Event Report: COOK INC SPHERE INFLATION DEVICE; MAV SYRINGE, BALLOON INFLATION

Catalog Number	CID-20-30
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant devices: 6 x 10 cm pta balloon, v18 guidewire.(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, an arteriovenous fistula (avf) angioplasty procedure was initiated via brachial artery to treat a lesion in the cephalic vein arch.Patient's anatomy was neither torturous, angulated nor calcified.The physician intended to inflate a 6x10 centimeter (cm) percutaneous transluminal angioplasty balloon (manufacturer not specified) to 10 atmospheres (atm) using a mixture of contrast to saline in a 1:1 ratio without success.A fracture was noted at the body of the sphere inflation device.As a result, the physician was unable to inflate the angioplasty balloon.The complaint device was changed out for a new sphere inflation device which allowed the procedure to be completed successfully.According to the complainant, no patient adverse effects occurred as a result of this occurrence.
Additional Manufacturer Narrative
Additionally, upon return of investigation and review of the event, it has been determined that this is not a reportable event per cfr 21 803.20 (c)(1).Investigation ¿ evaluation.A review of the complaint history, specifications, drawing , and a visual inspection and functional evaluation of the returned device were conducted during the investigation.Functional testing of the device was conducted with distilled water.The device would not build pressure, but rather leaked from the hose at the socket area, as seen in the attached closure form.Under magnification, the outer layer of the hose was determined to be compromised.A tear in the hose at socket location was noted.Additionally, a document based investigation evaluation was performed by the supplier.There is no evidence to suggest the product was not made to specifications.A review of the lot number 96271386 in the complaint database yielded two additional complaints reported.Based on the information provided, the examination of the returned product, and the results of our investigation, the root cause is traced to transport/storage.We will continue to monitor for similar complaints.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: SPHERE INFLATION DEVICE
• Common Device Name: MAV SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7720205
• Report Number: 1820334-2018-02122
• Device Sequence Number: 1107942
• Product Code: MAV
• UDI-Device Identifier: 10827002310275
• UDI-Public: (01)10827002310275(17)210228(10)96271386
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K953522
• 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): 10/05/2018

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: 02/28/2021
• Device Catalogue Number: CID-20-30
• Device Lot Number: 96271386
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1