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

Catalog Number CID-20-30

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Occupation: unknown.(b)(6).A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a cystoscopy procedure with urethral dilation and insertion of cbd, a cook sphere inflation device gauge did not function as intended, resulting in rupture of a cook urethral dilation balloon catheter.Reportedly, another manufacturer's safety guide wire was inserted into the body and the inflation device syringe was filled with contrast.The urethral balloon was connected to the inflation device, and the balloon was inserted over the wire.The balloon was inflated with the complaint device; however the gauge was reportedly not accurate and caused the balloon to rupture in the body.A "pop" was heard and the patient complained of slight pain at the time of rupture.Per the reporter, as the balloon was inflated, the needle of the gauge did move "a little bit", but did not increase as the balloon was inflated.The patient did not suffer any injury resulting from the event.The procedure was aborted; however, no further treatment was required, as the urethra had been dilated.The patient was discharged to home.There has been no report that any part of the device remained in the patient's body, that the patient required any additional procedures, or that the patient experienced any adverse effects due to this event.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

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, documentation, instructions for use (ifu), manufacturing instructions, and quality control procedures of the device and a visual inspection and functional test of another device from the same product lot were conducted during the investigation.As this device is provided by a supplier, an investigation was performed by the supplier.A device from the same product lot as the complaint device was returned by the user facility.Visual inspection and functional testing of this device showed that the device measured within specification in all gauge tests.The device exhibited a witness mark, indicating that the device passed functional testing during inspection prior to shipment.No visual anomalies were noted.A review of the device history records by the supplier for the complaint lot indicated that the devices were manufactured under normal operating procedures.Additionally, final product complaints are reported and logged with cook.One additional complaint was submitted from the product lot.This complaint was submitted in an mdr under patient identifier (b)(6).Based on the information provided and the examination of the returned product, investigation has concluded that a cause for the device failure could not be established.It is possible that the reported device failure could have occurred due to patient anatomy or procedural factors.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

This report is being submitted as a correction.Upon further review, it has been determined that atrion is the labeled manufacturer of the complaint device and is therefore responsible for all regulatory reporting and complaint investigation requirements.The complaint information has been provided to the manufacturer (atrion) and entered in the complaint file by cook inc.

Event 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
• Type of Device: MAV SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9082886
• MDR Text Key: 165625351
• Report Number: 1820334-2019-02355
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 10827002310275
• UDI-Public: (01)10827002310275(17)211031(10)96271402
• Combination Product (y/n): N
• PMA/PMN Number: K953522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: CID-20-30
• Device Lot Number: 96271402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 01/29/2020; 05/03/2021
• Supplement Dates FDA Received: 02/03/2020; 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1