MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) JAGWIRE¿; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number M00556561

Device Problem No Apparent Adverse Event (3189)

Patient Problem Inflammation (1932)

Event Date 01/16/2017

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a jagwire¿ guidewire was used in a bile duct stone removal procedure on (b)(6) 2017.According to the complainant, during the procedure, cannulation was performed using a truetome and jagwire.The jagwire guidewire was placed in the pancreatic duct, while approaching the bile duct by pancreatic duct it was noticed that the tip of the jagwire coating peeled off.However, the procedure was completed with this jagwire guidewire.After the procedure it was reported the patient had pancreatitis.In the physician¿s opinion, use of the guidewire in the pancreatic duct caused the pancreatitis.The patient remained under observation.Reportedly, it was confirmed under fluoroscopy no particles remained in the pancreatic duct.

Manufacturer Narrative

A visual examination of the guidewire revealed that the distal tip was detached exposing the tip of the metal corewire, approximately 0.3 cm.Presence of adhesive remnants and sanding marks were found indicating that the pebax was properly attached to the corewire.No evidence of corewire fractured.It was noted that the condition of the returned device could not be evaluated with respect to the reported event "pancreatitis".The complaint is due to a known physiological effect of the procedure noted within the directions for use.Based on all gathered information, the most probable root cause is "anticipated procedural complication." 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 batch.A labeling review was performed and there is no evidence that the device was not used in accordance with the labeling.

Event Description

It was reported to boston scientific corporation that a jagwire¿ guidewire was used in a bile duct stone removal procedure on (b)(6) 2017.According to the complainant, during the procedure, cannulation was performed using a truetome and jagwire.The jagwire guidewire was placed in the pancreatic duct, while approaching the bile duct by pancreatic duct it was noticed that the tip of the jagwire coating peeled off.However, the procedure was completed with this jagwire guidewire.After the procedure it was reported the patient had pancreatitis.In the physician¿s opinion, use of the guidewire in the pancreatic duct caused the pancreatitis.The patient remained under observation.Reportedly, it was confirmed under fluoroscopy no particles remained in the pancreatic duct.

• Brand Name: JAGWIRE¿
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6323988
• MDR Text Key: 67206557
• Report Number: 3005099803-2017-00412
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• PMA/PMN Number: K141820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2017
• Device Model Number: M00556561
• Device Catalogue Number: 5656
• Device Lot Number: 16903250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 02/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2014
• 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 Outcome(s): Hospitalization