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

Model Number M00550320

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported.The complainant was unable to report the device lot number; therefore, the manufacture and expiration date is unknown.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, 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 lungs during a bronchoscopy procedure performed on an unknown date.According to the complainant, during the procedure, the balloon was broken.There were no patient complications reported as a result of the 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.

• Brand Name: CRE PULMONARY
• Type of Device: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road,; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 7953027
• MDR Text Key: 123298768
• Report Number: 3005099803-2018-60697
• Device Sequence Number: 1
• Product Code: KTI
• UDI-Device Identifier: 08714729456209
• UDI-Public: 08714729456209
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/10/2018

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
• Device Operator: Health Professional
• Device Model Number: M00550320
• Device Catalogue Number: 55740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2018
• Initial Date FDA Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1