MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (SUD) OPTICROSS?; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number H749518080

Device Problems Kinked (1339); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2014

Event Type  malfunction  

Event Description

Same cases as: 2134265-2014-05701 and 2134265-2014-05702.It was reported that an automatic pullback failure occurred.The unknown target lesion was mildly calcified and mildly tortuous.During the percutaneous coronary intervention (pci) procedure, an ilab ultrasound imaging system was used in conjunction with an opticross¿ imaging catheter in order to visualize the unknown target lesion.The physician attempted to perform automatic pullback, however, pullback failure occurred.Consequently, when the physician removed the opticross¿ imaging catheter from the patient, it was further noted that the shaft of the device was kinked.The physician did not feel any resistance when using the device.The procedure was then completed using another of the same device.No patient complications were reported and the patient is in good status.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer: the complaint device was received for evaluation.After device analysis, the following were observed: kinks were observed in the telescope assembly at 72.5cm from femoral marker to the proximal end and in the imaging window assembly at 97.5cm & 85.9cm from femoral marker to the distal end.The telescope assembly was not able to properly pull back, advance, and retract due to multiple kinks on the imaging window and telescope.The telescope cannot advance the transducer distal housing (tdh) to the most distal position.A good square image appeared in the system and the product performed within specification.No 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

Same cases as: 2134265-2014-05701 and 2134265-2014-05702.It was reported that an automatic pullback failure occurred.The unknown target lesion was mildly calcified and mildly tortuous.During the percutaneous coronary intervention (pci) procedure, an ilab ultrasound imaging system was used in conjunction with an opticross¿ imaging catheter in order to visualize the unknown target lesion.The physician attempted to perform automatic pullback, however, pullback failure occurred.Consequently, when the physician removed the opticross¿ imaging catheter from the patient, it was further noted that the shaft of the device was kinked.The physician did not feel any resistance when using the device.The procedure was then completed using another of the same device.No patient complications were reported and the patient is in good status.

• Brand Name: OPTICROSS?
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• 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: 4111326
• MDR Text Key: 20016286
• Report Number: 2134265-2014-05624
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• PMA/PMN Number: K123621
• 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: 08/28/2014

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: 07/01/2015
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 17092036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2014
• Initial Date FDA Received: 09/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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