MAUDE Adverse Event Report: COVIDIEN NANOCROSS 0.14 OTW PTA DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number AB14W020150090

Device Problem Difficult to Remove (1528)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/06/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

During procedure, the nanocross balloon was inflated at the below knee.Then the physician tried to remove the device from the patient but it got stuck near f-p anastomotic region, and the device did not move back and forth.Resistance was noted passing the lesion.When the physician pulled the device, the shaft started stretching and was reported to be difficult to be removed.The device was removed by open surgery; the distal of the puncture site was dissected to remove the device.The lesion exhibited 90% stenosis, mild tortuosity with 60 mm lesion length.The device was removed successfully.Current status of the patient is reported to be fine.

Manufacturer Narrative

Device evaluation summary: the nanocross elite was received in two segments.The most distal segment appears to be the balloon chamber inverted on itself.Both segments were on 0.014¿ guide wire.The proximal segment of the nanocross elite was examined.The inflation lumen is terminated approximately 73.7 cm distal of the manifold¿s printed strain relief distal tip.The blue inner guidewire lumen appears to neck down onto the guidewire due to stretching.The blue inner guide wire lumen terminates approximately 111.2 cm distal of the manifold¿s printed strain relief distal tip.The overall working length of the nanocross elite is 90 cm, based on the returned length of the inner guidewire lumen it has been stretched approximately 21 cm.The distal end of the guide wire terminates in a sharp kink.At the kink two of the four radiopaque markers are visible.The radiopaque markers are free to move along the guide wire.The distal segment consists mainly of the balloon chamber stripped off the catheter.The balloon chamber material exhibits accordion folding and is inverted upon its distal end.The length of 0.014¿ guidewire the balloon chamber is on is approximately 52.7 cm in length.Both ends of the guidewire exhibit kinks.The balloon chamber material slides freely over the guidewire.The balloon chamber material could be slid off the guidewire for further examination.Approximately 123 mm of the balloon chamber was returned non-inverted.Approximately 23 mm of the balloon chamber is inverted.The distal tip and a segment of the guidewire lumen was found attached to the distal end of the balloon chamber.The balloon chamber was soaked in water to improve clarity of the photographs.The distal balloon marker band was found loose within the balloon chamber.The proximal balloon bond exhibits tensile shearing from the inflation lumen.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: NANOCROSS 0.14 OTW PTA DILATATION CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6383326
• MDR Text Key: 69204138
• Report Number: 2183870-2017-00105
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Model Number: AB14W020150090
• Device Catalogue Number: AB14W020150090
• Device Lot Number: A220052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2016
• 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): Required Intervention
• Patient Age: 63 YR