MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENCORE 26; SYRINGE, BALLOON INFLATION

Model Number M0067101140

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a nephromax balloon kit was used during a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noticed that a long hair was wrapped in and around the inflation device.No patient complications have been reported due to this event.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Block h6: problem code 2969 captures the reportable issue of foreign matter.Block h10: although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a nephromax balloon kit was used during a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noticed that a long hair was wrapped in and around the inflation device.No patient complications have been reported due to this event.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Event Description

It was reported to boston scientific corporation that a nephromax balloon kit was used during a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noticed that a long hair was wrapped in and around the inflation device.No patient complications have been reported due to this event.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Block h6: problem code 2969 captures the reportable issue of foreign matter.Block h10: investigation results an encore device was returned inside of its original box, but was returned without its tray.Visual examination inside of the box revealed a human hair adhered to the clear window of the box; however, the device was not close to the human hair which indicated that the hair did not breach the sterile barrier of the tray and also would not impact the quality of the device.Additionally, the device did not show damages, was in good condition and the syringe barrel had a non-identified liquid.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• Brand Name: ENCORE 26
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8771013
• MDR Text Key: 150415580
• Report Number: 3005099803-2019-03442
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729077589
• UDI-Public: 08714729077589
• Combination Product (y/n): N
• PMA/PMN Number: K955869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2019

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: 01/06/2022
• Device Model Number: M0067101140
• Device Catalogue Number: 710-114
• Device Lot Number: 0023149019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 07/10/2019; 08/20/2019
• Supplement Dates FDA Received: 07/23/2019; 09/11/2019
• Patient Sequence Number: 1