MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK CRE¿ WIREGUIDED; DILATOR, ESOPHAGEAL

Model Number M00558460

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.It was reported the device was not used past its expiry date.(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 cre wireguided dilatation balloon was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2016.According to the complainant, on (b)(6) 2016, the physician attempted to pass a biopsy forceps through the biopsy channel of the same endoscope used with the cre balloon on (b)(6) 2016, and resistance was met.The endoscope was removed from the patient, and they found the exit marker from the cre balloon inside of it.They removed the exit marker from the endoscope, and no part of the device fell into the patient.The procedure was completed at this time.No patient complications have been reported as a result of this event.

• Brand Name: CRE¿ WIREGUIDED
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5769998
• MDR Text Key: 48815000
• Report Number: 3005099803-2016-01904
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110833
• 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: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00558460
• Device Catalogue Number: 5846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2016
• 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
• Patient Age: 54 YR