MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WANDA¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number H965SCH505060

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that a foreign matter was found on the balloon catheter.The 90% stenosed target lesion was located in the severely tortuous and mildly calcified right common iliac artery (rcia).Following deployment of a wallstent, a 5.0-20, 80 wanda¿ balloon catheter was advanced for post-dilation but could not be inserted.However, when the sheath was pulled out and flushing was performed, a yellow resin-like object came out.The foreign object got caught and the balloon catheter could not be inserted.The device was completely removed from the patient and the procedure was completed with 5.0-40mm wanda balloon catheter.There were no patient complications nor injuries reported.

Manufacturer Narrative

Describe event or problem.Updated.(b)(4).

Event Description

It was further reported that the sheath was flushed which produced the yellow residue and the foreign object got caught on the guide sheath.

Manufacturer Narrative

Device evaluated by mfr: received for analysis was the wanda device, a wallstent device, a 0.035inch size guidewire.Also received was a green / yellow piece of foreign material (fm).The fm was in two sections.One section measured approximately 10mm in length and the second section measured approximately 15mm in length.An examination of the wanda device identified no kinks or damage.The balloon was not tightly folded.No damage was observed with the tip section of the device.As part of the device analysis a 0.035inch size wire freely passed through the wire lumen with no resistance.No fm was pushed out from the wanda device.An examination of the wallstent unit identified that the stent had been deployed and was not received for analysis.The shaft of the wallstent was kinked at 23.2cm distal to the t-bar.This kink may have occurred during the handling of the device during its return for analysis as the complaint does not reference any issues with the wallstent during use.No other issues were noted with the wallstent.A 0.035inch wire passed through the device with no anomalies noted.The fm material was sent for ftir spectroscopy.This resulted in a 73% match to polyimide iv.Some samples from the components used in the wallstent and the wanda device were sent for the same ftir testing.Both displayed a different spectra to that of the fm sample.No other issues were noted.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable cause of the reported difficulties may be due interaction with another device.(b)(4).

Event Description

It was further reported that the sheath was flushed which produced the yellow residue and the foreign object got caught on the guide sheath.

• Brand Name: WANDA¿
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6508702
• MDR Text Key: 73344592
• Report Number: 2134265-2017-03806
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• 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,Followup
• Report Date: 03/31/2017

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: 05/11/2017
• Device Model Number: H965SCH505060
• Device Catalogue Number: SCH-50506
• Device Lot Number: 17439898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2017
• Initial Date FDA Received: 04/20/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/12/2017; 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2014
• 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
• Treatment: GUIDE WIRE: 035 RADIFOCUS; STENT: WALLSTENT