MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: BERMAN 5 FR 50CM; BERMAN ANGIOGRAPHIC CATHETER PRODUCT

Catalog Number AI-07130

Device Problems Deflation Problem (1149); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2014

Event Type  malfunction  

Event Description

It was reported that the event occurred in the cath lab.The md performed the inflation test before inserting the catheter using the syringe packaged in the set.At that time, the inflation/deflation behaviors were normal.The md inserted the berman catheter via the pt's right femoral vein.While inflating the balloon the md felt that the balloon appeared to deflate in slow-motion.Therefore, the berman catheter was removed and a new one was inserted with no delay or interruption.The doctor uses more than 100 berman catheters per year.The md said the defect was found from his experience; in this case, the timings of starting inflating / deflating were quite slower than usual.The second product insertion was successful.There were no reported pt complications, death or injury.Medical / surgical intervention was not required.The pt outcome is listed as good.

Manufacturer Narrative

(b)(4).

• Brand Name: CATH PKGD: BERMAN 5 FR 50CM
• Type of Device: BERMAN ANGIOGRAPHIC CATHETER PRODUCT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth dr; chelmsford MA 01824
• Manufacturer Contact: anne rosenberger,clinical spec ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 4240009
• MDR Text Key: 4993562
• Report Number: 3010532612-2014-00030
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K892530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: AI-07130
• Device Lot Number: 16F14D0106
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2014
• 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