MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (SUD) ATLANTIS? SR PRO; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number H749389420

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2014

Event Type  malfunction  

Event Description

It was reported that a fracture in the catheter was noted.The target lesion was located in the right coronary artery (rca).During a percutaneous coronary intervention (pci), that an atlantis¿ sr pro imaging catheter was used in order to visualize the target lesion.However, a fracture was noted in the device.The procedure was then completed using another of the same device.No patient complications were reported and the patient status is stable.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer: the complaint device was received for evaluation.After device analysis, a kink was observed in the sheath assembly at 27.0 cm from femoral marker to the distal end.There was no evidence of detachments in any section of the catheter.No other issues or defects were observed during product analysis of the returned device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that a fracture in the catheter was noted.The target lesion was located in the right coronary artery (rca).During a percutaneous coronary intervention (pci), that an atlantis¿ sr pro imaging catheter was used in order to visualize the target lesion.However, a fracture was noted in the device.The procedure was then completed using another of the same device.No patient complications were reported and the patient status is stable.

• Brand Name: ATLANTIS? SR PRO
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4341221
• MDR Text Key: 18031563
• Report Number: 2134265-2014-08221
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K063312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2014

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 Expiration Date: 08/27/2015
• Device Model Number: H749389420
• Device Catalogue Number: 38942
• Device Lot Number: 17234631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2015
• Initial Date FDA Received: 12/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2014
• 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 Age: 56 YR
• Patient Weight: 71