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

Model Number M00556581

Device Problems Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017)

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

Event Type  Injury  

Manufacturer Narrative

(b)(6).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a jagwire was used during a lower limb angioplasty procedure.According to the complainant, during procedure, the physician observed that the floppy tip of the guidewire was peeling and offering risk of embolization of intravascular foreign body.Additionally, the directions for use indicate "the jagwire high performance guidewire is indicated for use in selective cannulation of the biliary ducts including, but not limited to the common bile, cystic, right and left hepatic ducts.The jagwire high performance guidewire is designed to be used during endoscopic biliary procedures for catheter introduction and exchanges.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.

Event Description

It was reported to boston scientific corporation that a jagwire was used during a lower limb angioplasty procedure.According to the complainant, during procedure, the physician observed that the floppy tip of the guidewire was peeling and offering risk of embolization of intravascular foreign body.Additionally, the directions for use indicate "the jagwire high performance guidewire is indicated for use in selective cannulation of the biliary ducts including, but not limited to the common bile, cystic, right and left hepatic ducts.The jagwire high performance guidewire is designed to be used during endoscopic biliary procedures for catheter introduction and exchanges.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

(b)(4).

Event Description

It was reported to boston scientific corporation that a jagwire was used during a lower limb angioplasty procedure.According to the complainant, during procedure, the physician observed that the floppy tip of the guidewire was peeling and offering risk of embolization of intravascular foreign body.Additionally, the directions for use indicate "the jagwire high performance guidewire is indicated for use in selective cannulation of the biliary ducts including, but not limited to the common bile, cystic, right and left hepatic ducts.The jagwire high performance guidewire is designed to be used during endoscopic biliary procedures for catheter introduction and exchanges.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

Correction: adverse event or product problem, (outcomes attributed to adverse event).

Event Description

It was reported to boston scientific corporation that a jagwire was used during a lower limb angioplasty procedure.According to the complainant, during procedure, the physician observed that the floppy tip of the guidewire was peeling and offering risk of embolization of intravascular foreign body.Additionally, the directions for use indicate "the jagwire high performance guidewire is indicated for use in selective cannulation of the biliary ducts including, but not limited to the common bile, cystic, right and left hepatic ducts.The jagwire high performance guidewire is designed to be used during endoscopic biliary procedures for catheter introduction and exchanges.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: 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: 6747566
• MDR Text Key: 81183984
• Report Number: 3005099803-2017-02238
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 08714729339151
• UDI-Public: (01)08714729339151(17)20180901(10)18363526
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/04/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Model Number: M00556581
• Device Catalogue Number: 5658
• Device Lot Number: 18363526
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/04/2017
• Initial Date FDA Received: 07/27/2017
• Supplement Dates Manufacturer Received: 09/01/2017; 09/11/2017; 09/13/2017
• Supplement Dates FDA Received: 09/01/2017; 09/12/2017; 09/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2015
• 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
• Patient Outcome(s): Other