MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PULMONARY; BRONCHOSCOPE ACCESSORY

Model Number M00550350

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 cre pulmonary dilatation balloon was used in the right main stem during a bronchoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, upon inflation, the balloon burst at the recommended pressure for the dilation size.Reportedly, the balloon was retrieved with biopsy forceps.The procedure was completed with another cre pulmonary dilatation balloon.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Problem code 1074 captures the reportable issue of balloon burst.Problem code 2907 captures the reportable issue of balloon material detached.Investigation results: a visual examination of the returned complaint device revealed the catheter was found broken near the balloon hub and the balloon portion of the device was not returned.Functional analysis was unable to be performed due to the returned condition of the device.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause is cause not established.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the right main stem during a bronchoscopy procedure performed on (b)(6), 2019.According to the complainant, during the procedure, upon inflation, the balloon burst at the recommended pressure for the dilation size.Reportedly, the balloon was retrieved with biopsy forceps.The procedure was completed with another cre pulmonary dilatation balloon.There were no patient complications reported as a result of this event.

• Brand Name: CRE PULMONARY
• Type of Device: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8583047
• MDR Text Key: 144160034
• Report Number: 3005099803-2019-02310
• Device Sequence Number: 1
• Product Code: KTI
• UDI-Device Identifier: 08714729456230
• UDI-Public: 08714729456230
• Combination Product (y/n): N
• PMA/PMN Number: K023337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2021
• Device Model Number: M00550350
• Device Catalogue Number: 5035
• Device Lot Number: 0022268354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/06/2019
• Supplement Dates Manufacturer Received: 05/26/2019
• Supplement Dates FDA Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention