MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER SPYSCOPE DS ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00546600

Device Problem Device Packaging Compromised (2916)

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

Event Type  malfunction  

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 spyscope digital access and delivery catheter was prepared for an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, during preparation, as they were about to use the spyscope ds, which was found on the top of the cabinet, it was noticed that the packaging was already opened and the sterile barrier appeared compromised.Additionally, the strap of the device was found broken.Reportedly, the device condition did not have any signs of use when they checked the device.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Visual inspection of the returned unit revealed that there was a continuous imprint that around the entire edge of the tray lid/label; this imprint was made by the sealer when the label/lid was affixed to the tray.Based on the evidence observed on the returned label/lid, the seal impression on the lid meets specification.The mating tray was not returned.The handle strap was broken where the strap enters the strap based on the handle.There were no voids in the material at the break on the section that remained attached to the handle or the detached portion.There were no sharp edges or flash on the portion of the strap base that holds the strap.The strap appeared to be properly installed into the strap base during manufacturing.A dimensional verification was performed and found that it meets within specification.Based on the evidence observed on the returned label/lid, the seal impression on the lid meets that specification.The mating tray was not returned.During manufacturing, the packaged device tray seals are 100% verified.Given the tray was not returned for evaluation; the most probable root cause is undeterminable.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was prepared for an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, during preparation, as they were about to use the spyscope ds, which was found on the top of the cabinet, it was noticed that the packaging was already opened and the sterile barrier appeared compromised.Additionally, the strap of the device was found broken.Reportedly, the device condition did not have any signs of use when they checked the device.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: SPYSCOPE DS ACCESS & DELIVERY CATHETER
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5463848
• MDR Text Key: 39163225
• Report Number: 3005099803-2016-00471
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 18647172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1