MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 6 FR 110 CM; THERMODILUTION BALLOON CATHETER

Catalog Number AI-07126

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212); Material Fragmentation (1261)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 05/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a right heart catheterization procedure, the catheter was inserted into the right internal jugular vein using a 6fr sheath as an access port.While removing the catheter over the sheath, the catheter came out with some difficulty and the balloon was detached from the catheter.It was reported that the balloon was lost and it was impossible to locate the balloon under fluoroscopy.There is no reported death or serious injury.According to information teleflex received, the patient was sent home following the procedure.

Manufacturer Narrative

(b)(4) teleflex did not receive the device for analysis therefore the reported complaint that the balloon detached from the catheter is not able to be confirmed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.

Event Description

It was reported that during a right heart catheterization procedure, the catheter was inserted into the right internal jugular vein using a 6fr sheath as an access port.While removing the catheter over the sheath, the catheter came out with some difficulty and the balloon was detached from the catheter.It was reported that the balloon was lost and it was impossible to locate the balloon under fluoroscopy.There is no reported death or serious injury.According to information teleflex received, the patient was sent home following the procedure.

• Brand Name: CATH PKGD: WEDGE 6 FR 110 CM
• Type of Device: THERMODILUTION BALLOON CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6606051
• MDR Text Key: 76478747
• Report Number: 1219856-2017-00126
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K892530
• 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
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F15M0053
• Other Device ID Number: 00801902002877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2015
• 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: 70 YR
• Patient Weight: 110